Biologic License Applications to OCTGTRamani Sista Ph.D., RAC, CQA gives an overview of the type of inflation and format to include in the submission of a Biologics License Application to CBER’s Office of Cellular, Tissue, and Gene Therapies....

Early-Phase Trials of Cellular and Gene TherapiesSteve Winitsky, MD's presentation reviews some of the major clinical risks associated with cellular and gene therapy products and will discuss some considerations for clinical protocol design that are relevant to these products.

Special Protocol Assessment (SPA)Steve Winitsky, MD provides some background and information on a 2016 draft guidance document related to the Special Protocol Assessment (SPA) process.